Preterm Infants Often Get Non-Indicated GERD Tx

No evidence for efficacy in infants, but NICUs use it anyway

Nearly a quarter of newborn infants received acid-suppressive medications mainly for treatment of gastroesophageal reflux disease (GERD), despite limited evidence of benefit in the neonate population, a large retrospective cohort study of 43 U.S. children's hospitals found.

Overall, there were 23.8% of infants who ever received either a histamine-2 receptor (H2R) antagonist or a proton pump inhibitor. Notably, over a quarter of extremely preterm infants (≤24 weeks) and infants 25-26 weeks were treated with H2R agonists, reported Jonathan L. Slaughter, MD, of Nationwide Children's Hospital in Columbus, Ohio, and colleagues.

In adjusted models, infants diagnosed with GERD had a more than five-fold risk of ever receiving a proton pump inhibitor (RR 5.37) and were more than twice as likely to be treated with an H2R antagonist (RR 2.68), the researchers wrote in the Journal of Pediatrics.

In an email interview with MedPage Today, Slaughter said that he thought the most surprising finding of the study was the wide variation in prescribing practices across hospitals, despite limited evidence that the practices are even indicated for the neonatal population.

"The high frequency of acid suppressive use in neonatal intensive care units should be of concern to clinicians and make the neonatal community as a whole reevaluate our use of these medications," he said. "Despite almost no data showing that treatment of neonates with these medications improves clinical outcomes and an increasing amount of data showing an association with potentially harmful side effects, they have still been widely used."

The FDA has approved these drugs for children and older adults, but Slaughter and colleagues note that "neonatal trials have not demonstrated improvement in GERD-attributed clinical symptoms following [H2R antagonist] or PPI treatment."

But data from examined hospitals found that that more than half (56.0%) of patients treated with an H2R antagonist or a proton pump inhibitor were still receiving that treatment at discharge, with more than three-quarters of infants who had ever received a PPI remaining on that proton pump inhibitor (75.0%).

Slaughter attributes this inappropriate use of medications by NICUs to the lack of research on safety and effectiveness of these treatments for GERD in infants.

"Acid control helps older patients. Thus, neonatal physicians began prescribing them for neonatal GERD without prior research on the potential for H2R [antagonists] and PPIs to help or harm newborn babies," he said. "It appears neonatologists use these drugs in preterm and sick infants to treat [GERD] on the presumption that acid suppression will relieve concerning symptoms."

In addition to GERD, both infants with congenital heart disease and infants with ENT diagnoses were also more than twice as likely to be treated with an H2R antagonist or a proton pump inhibitor (RR 2.41 and RR 2.34, respectively) compared with infants without these conditions.

The authors examined data from a cohort of NICUs within the Pediatric Health Information System Database (n=122,002). A total of 11.2% of patients received an ICD-9 diagnosis of GERD, and of those patients, 74.3% were treated with either an H2R antagonist or a proton pump inhibitor. Median postnatal age for first treatment was 10 days (range 0-361) and median treatment duration was 15 days (range 1-1,244).

Slaughter said that safety research on existing neonatal medications, which are frequently used, should be as high a national and international priority as new drug development.

"In the future, medications that are considered for use in neonates should be fully tested in neonates before wide adoption by the neonatal community," he said. "The recent concerns for associations between PPI use and chronic renal disease in adults highlights the need for proper databases to allow researchers to follow neonatal patients into adulthood and detect the potential positive and negative long-term effects of neonatal medication treatment on adult outcomes."

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